Real-world evidence (RWE) is the collection of information about a drug’s safety and efficacy outside structured clinical trials, e.g. registries, chart reviews, cohort studies, cost-effectiveness studies, etc. This data is often viewed as lower quality and more biased than randomized controlled trials (RCTs), although regulatory bodies are beginning to recognize its value.
The FDA recently adopted a consistent approach for considering RWE, including through “hybrid clinical trials” which incorporate aspects of RCTs and RWE. These trials are less time-consuming and costly than RCTs, while ultimately increasing our knowledge about a drug.
In Canada, the Pharmaceutical Advertising Advisory Board (PAAB) has proposed new guidance on advertising claims based on the use of RWE to:
• Corroborate existing therapeutic and safety claims
• Support therapeutic and safety claims in separate populations
• Relate to new measures such as adherence, market dynamics and disease epidemiology.
The proposed change will broaden the scope of evidence that can be used to support advertising claims, however core principles of the Code remain (i.e. consistency with a product’s terms of market authorization and data must be of high quality). The PAAB is accepting comments on the proposed changes until January 31st, following which the board will vote on implementing the new guidance.